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FDA 510(k)

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

K-Number: K260397 · 2026-04-06

ApplicantHironic Co., Ltd.
Decision Date2026-04-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K260397. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K260397.

When did SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) receive FDA 510(k) clearance?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K260397.

Who is the listed applicant for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

The FDA 510(k) record lists Hironic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

The FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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